Tatabanya, Szombathely, Csorna, Budapest, Balassagyarmat, Hungary
Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
To evaluate safety and tolerability of CBD-based drug product at different doses
Phase
2Span
105 weeksSponsor
Laboratorio Elea Phoenix S.A.Mendoza
Recruiting
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Buloxibutid is an oral angiotensin II type 2 (AT2) receptor agonist and has been shown to improve lung function in IPF over 36 weeks. Buloxibutid agonizes the AT2 receptor on alveolar epithelial type 2 cells (AEC2s), which are believed to play a central role in the disease. Buloxibutid has been demonstrated preclinically to improve AEC2 viability, alveolar integrity via surfactant secretion and epithelial repair via replenishment of gas exchange alveolar epithelial type 1 cells (AEC1s). This leads to decreasing downstream profibrotic signaling, enhancing resolution of existing fibrotic tissue via upregulation of collagenase matrix metalloproteinases, and addressing vascular disfunction associated with the disease. The trial will include participants who are on stable licensed IPF therapy or who are currently not treated with a licensed IPF therapy. The latter group will include participants intolerant or not responsive to licensed IPF therapies, participants ineligible to receive these therapies, and participants who have voluntarily declined to receive a licensed IPF therapy after being fully informed of the potential benefits and risks of such therapy. Due to the potential risk of drug-drug interactions (DDIs), concomitant treatment with pirfenidone is not allowed in this trial. Participants who are not on antifibrotic therapy at study start may initiate such treatment during the study. The trial is planned to enroll 270 participants, 90 participants on oral buloxibutid 100 mg BID, 90 participants on oral buloxibutid 50 mg BID, and 90 participants on oral placebo BID for 52 weeks. The treatment will be blinded and treatment allocation will be randomized. The primary measurement will be based on spirometry, measuring the forced vital capacity (FVC). The trial consists of 3 consecutive periods: a screening period of up to 6 weeks, a 52-week treatment period, and a follow-up period of 2-4 weeks after the 52-week visit. The study procedures have been planned with focus on optimizing patient convenience while allowing a safe conduct and strict scientific rigor. Trial website: www.aspire-ipf.com
Phase
2Span
121 weeksSponsor
Vicore Pharma ABMendoza
Recruiting
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Phase
3Span
148 weeksSponsor
AmgenMendoza
Recruiting
Argentine Registry of Lp(a)
Phase
N/ASpan
105 weeksSponsor
School of Medicine. National University of CuyoMendoza
Recruiting
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Phase
3Span
265 weeksSponsor
Eli Lilly and CompanyMendoza
Recruiting
A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Phase
2Span
103 weeksSponsor
GlaxoSmithKlineMendoza
Recruiting
Mendoza
Recruiting
Efficacy of INM004 in Children With STEC-HUS
The primary objective will be to evaluate the efficacy of INM004, added to the standard of care, as a treatment for STEC-HUS in the amelioration of renal function. Secondary objectives - To evaluate the efficacy of INM004 in the reduction of mortality. - To evaluate the efficacy of INM004 in the prevention and reduction of extrarenal complications. - To evaluate the efficacy of INM004 in the improvement of TMA laboratory parameters. - To evaluate the efficacy of INM004 in the reduction of hospital stay days. - To evaluate the safety of INM004 - To evaluate the pharmacokinetics of INM004 - To evaluate the kinetics of Stx
Phase
3Span
52 weeksSponsor
Inmunova S.A.Mendoza
Recruiting
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
This is a phase-3 multicentre, double-blind, parallel-group placebo-controlled, randomised study. The study will comprise of: 1. Screening/Run-in period of 4 to 6 weeks, 2. 52-week double-blind Treatment period, 3. Post-treatment Follow-up period of 12 weeks. Participants will be randomised 2:1 to receive either tezepelumab or placebo administered by (SC) Subcutaneous injections for 52 weeks (double-blind Treatment period). There will then be a 12-week off-treatment Follow-up period for participants who do not continue in the optional open-label Active Treatment Extension period. An optional open-label Active Treatment Extension will allow all eligible participants the opportunity to receive active treatment with tezepelumab. The Active Treatment Extension period of the study will start following the 52-week double-blind Treatment period and will consist of a 24-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.
Phase
3Span
228 weeksSponsor
AstraZenecaMendoza
Recruiting
Mendoza
Recruiting